The packing of individual products in individual containers sized for single use is becoming increasingly common for a variety of products that have previously been packaged in bulk forms. Because this transition is occurring most rapidly with respect to medical products, this type of packaging is often referred to as unit dose packaging. In some types of unit dose packaging each product has a separate container. However, this can lead to inefficiencies in manufacturing and can complicate handling by requiring the management of a multiplicity of individual items.
Accordingly, another type of unit dose packaging has emerged having a plurality of separate non-reusable unit dose containers that are physically linked often in a manner that allows the separation of the unit dose containers if later desired. For example, it is commonly known to package a plurality of pills using what is known as a blister pack. This approach provides a form of unit dose packaging that can be manufactured and handled more efficiently than separate but individual packages of pills.
Various examples of blister packs are described in WO 97/20754, entitled: “Reinforced Blister Pack”. As is noted therein, blister packs generally comprise a pattern of blisters formed in a sheet of substantially impermeable deformable plastics material, each blister defining a cavity for the containment of a tablet. The open face of the blister is closed with a film cover, usually a thin, tearable metal foil or a peel-off film. The film cover can either be easily ruptured, or the film can be easily peeled away from the blister. In use either the blister is compressibly deformed so as to force the tablet therein out though a rupturable film, or the film is peeled off and the tablet is removed from the cavity. Generally the deformable material is a stiff but relatively flexible material such as a plastic material or a plastic material laminate or plastic material metal foil laminate. WO 97/20754 provides a blister pack having reinforced material between blisters to confer rigidity relative to flexing deformation of the blister pack and is said to facilitate handling by users with weak or deformed hands.
FIG. 1a is a front view and FIG. 1b is a side view of a prior art blister pack 6 used for unit dose packaging of pills 12. In the example of FIGS. 1a and 1b, blister pack 6 provides a container tray 8 with a plurality of individual containment areas 10 that can each receive one of thirty one pills 12 and a film 14 that is joined to container tray 8 and support 20 to contain pills 12 within containment areas 10. This arrangement conveniently allows packaging of an entire one month course of individual doses of pills 12. The embodiment of prior art blister pack 6 illustrated in FIGS. 1a and 1b is known in the art as a “push through pack” because it is necessary to push pills 12 through film 14 in order to access pills 12. The process of pushing pills 12 through film 14 alters prior art blister pack 10 in a variety of ways (for example, leaving an opening in film 14 at the containment area 10 from which pill 12 has been pushed). Such alterations provide a clear indication of which of pills 12 have been used, and which pills 12 remain available for use.
However, when pills 12 must be taken in a sequence and at particular times relative to each other, it is necessary to carefully prepare printed instructions and warnings. It is also necessary that the user carefully review and interpret the instructions, and properly execute the instructions to ensure that pills 12 are taken according to a desired treatment regime. This places a heavy burden on the manufacturer of pills 12 and upon the user of user pills 12 to make sure that the pills are used and taken in accordance with these instructions. Even when manufacturers and users both act diligently there can be confusion and errors in the timing, sequence and quantity of pills 12 to be taken which can negatively impact the efficacy of treatment. For example while prior art blister pack 6 requires a user to push pills 12 through film 14, leaving a clear indication that certain of pills 12 have been accessed, there is no inherent indication of when pills 12 were accessed.
Accordingly, in the example of prior art blister pack 6 shown in FIGS. 1a and 1b, the manufacturer provides a variety of printed tools to help a user to resolve such problems. As shown, prior art blister pack 6 has a printed area 16 in which starting dates can be written and a calendar 18 which can be used to provide a user with some guidance on this point. However, even where such tools are used, a user of pills 12 can be confused as to which day they are in with respect to a multi day course of treatment. That is, a user who is to take a daily course of one pill per day can observe that prior art blister pack 6 has two containment areas 10 without pills 12 but cannot recall whether today is the second or third day of a course of treatment and will be left with weighing the risks of taking too much medication or too little medication today. Further, such expedients rely both on the correct entry and use of such information. Over the course of a thirty one day treatment regime confusion is still possible particularly where such users are in pain, fatigued, or taking medications that impair or otherwise limit their analytical abilities.
In other examples, some pills 12 must be taken according to a more rigorous schedule. For example, in some cases pills 12 are to be taken within 24 hours of each other during the course of therapy. However, problems can arise if a first one of pills 12 is taken at 6:00 a.m. on a first day of treatment and a second one of pills 12 is taken at 6:00 p.m. on a second day of treatment. Conversely, where a user is subject to a treatment regime that requires that a user take pills 12 no sooner than 24 hours apart, the tools and arrangement of the prior art blister pack 6 leave open the possibility that this regime will not be followed. For example, a user can dutifully use the tools on prior art blister pack 6 while taking a first one of pills 12 at 6 p.m. on a first day of treatment, and a second one of pills 12 at 6 a.m. on a second day treatment such that pills 12 are not taken according to the regime prescribed.
The individual packaging of pills 12 in prior art blister pack 6 can also be construed by some users as impliedly suggesting that pills 12 are to be taken one at a time. However, in some cases a course of pills 12 may require that a user take pills 12 in different doses over the course of treatment such that, for example, on a first day two pills 12 must be taken while on each of the following three days only one pill 12 is to be taken. Additionally, in some cases pills 12 can be taken according to more than one possible sequence or schedule. For example, when certain pills 12 are to be used on a periodic schedule, optional instructions can be provided to allow a user to consume a first one of pills 12 and then, if symptoms for which the pills 12 are being taken persist, the user can take a second pill 12 within a shorter than normal period. In such cases great care must be taken in preparing the printed instructions for such packaging and the risk of error arising through misreading instructions, misinterpreting instructions or inaccurate recollection of consumption cannot be eliminated.
This places a burden on a user to carefully manage usage of the products to accurately read, understand and follow instructions on prior art blister pack 6, and, as necessary, to set reminder systems, checklists or other processes to provide context in which to interpret the indications provided by prior art blister pack 6. Here too, while many users are capable of doing this, many pills 12 are intended for use by people whose ability to do so is limited by pain, fatigue, impaired judgment or the like. Additionally, there is the risk that a user may misunderstand the instructions, forget the instructions or specific details of the instructions.
Automatic reminder systems such as mechanical and electronic timers and clocks can be used to help remind a user as to when the user is to access the next unit dose. These devices require that the user secure such a timer and repeatedly reset the timer or otherwise program the timer so that the timer provides reminders at appropriate times. Mechanical timers have to be periodically rewound and electronic timers require batteries and need to be programmed by the user employing user interfaces with limited buttons and displays. Further, there is no inherent physical or logical integration between such timers and pills 12.
Also, automatic timers are not easily integrated into blister packs 6 as the physical format, low cost, and automated production of prior art blister packs 6 is made possible through the use of conventional blister pack manufacturing lines know in the art as “blisterlines”. These blisterlines use a process that involves laminating multiple films to form a container tray 8 having appropriately sized containment areas 10, loading pills 12 and applying film 14 to container tray 8. The blisterline tooling has been highly optimized to achieve greater productivity and to minimize the cost of manufacturing conventional blister packs 6. Accordingly such tooling cannot easily be adapted in the many ways that would be required to allow conventional blisterlines to incorporate automatic mechanical or electronic timers as these timers add significant cost, size, and complexity to such tooling.
Alternatively, it is possible for a user to use reusable pill management devices such as the MedReady 1600, sold by MedReady Inc., Torrance, Calif., USA, in which a user stores pills in separate containers that are linked to a timer that indicates when the contents of container are to be used. However, this approach requires the user to transfer pills 12 from the prior art blister pack 6 to the purchased device and then properly load and configure the device to the time period required. This creates risks that pills 12 can be lost, mixed, or degraded due to exposure to atmospheric gasses and humidity.
It will be appreciated that the problems associated with prior art blister packs 6 used for medical purposes exist more generally across a wide variety of products having a combination of individually packaged components that must be used in a particular sequence and at particular times in order to achieve desired results. Indeed, a wide variety of common consumer products include blister packed items or items that can potentially be packaged in a blister pack and that require careful adherence to potentially confusing instructions which require careful adherence to a sequence of activities; where certain activities are to be performed at predetermined timings relative to each other in order to achieve desired results. Examples of this include, but are not limited to, self assembled furniture kits, ingredient packages, repair kits, emergency kits, chemical preparation kits and the like.
What is needed in the art are new product containment systems that contain products to be used collectively to accomplish a result and that are to be used in a particular sequence and with particular timings.